13 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PROTEKT GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981080235·LIMITING TORQUE T-HANDLE
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112359·SURG-I-BAND PURPLE GLOW
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112267·SURG-I-BAND ORANGE
UF-760AG
FDA 510(k)
FDA Class 2
·Radiology
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830
FDA 510(k)
FDA Class 1
·Physical Medicine
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIV·Product code LGW·November 23, 2010
FORTIFY ASSURA DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 2, 2014
2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·January 5, 2018
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021